FDA MedWatch – Senhance Surgical System by Asensus Surgical

TOPIC: Senhance Surgical System by Asensus Surgical: Class I Recall – Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device

AUDIENCE: Patient, Health Professional, OB/GYN

ISSUE: Asensus Surgical is recalling the Senhance Surgical System due to malfunctions that cause unintended movement of the robotically-assisted surgical device. This issue presented itself as an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. The Senhance System is designed with emergency stop capabilities to stop this issue if observed.

There has been no patient impact or harm that has occurred due to this issue, however, the potential for critical tissue trauma is possible.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use. Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.

RECOMMENDATIONS: On September 15, 2023, Asensus Surgical sent all affected customers an Urgent Medical Device Recall letter.

The letter requested customers to:

• Stop use of the Senhance Surgical System until the Asensus Service Team has updated the device’s software to version 2.7.5.
• Sign the “Acknowledgement of Receipt” document, which was included in the letter, and return to Asensus Surgical.

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.